C3 Glomerulopathy
Conditions
Keywords
C3 glomerulopathy, C3G, Fabhalta
Brief summary
The objective of this study is to evaluate the safety and effectiveness of Fabhalta in patients with C3 glomerulopathy in clinical practice.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
0 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* All patients who have used Fabhalta for C3 glomerulopathy (including patients with recurrent C3 glomerulopathy post renal transplant).
Exclusion criteria
* Use of iptacopan for an indication not yet approved under the Clinical Trials Act or GCP (e.g., patient-requested medical treatment, investigator-initiated clinical trial)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with infections | 360 Days | Number of patients with infections and type of infections (meningococcal infection, pneumococcal infection, Haemophilus influenzae infection, and other infections based on the causative bacteria) as adverse events/adverse reactions during the treatment period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events and adverse reactions | 360 Days | Incidence of adverse events and adverse reactions that occurred during the treatment period |
| Changes in UPCR | Baseline, 360 Days | Changes in UPCR from baseline to Day 360 and from baseline to 360 days |
| Changes in eGFR | Baseline, 360 Days | Changes in eGFR from baseline to Day 360 and from baseline to 360 days |
| Proportion of patients achieving the composite renal endpoint at the final assessment. | 360 Days | The composite renal endpoint requirement will be met if the following criteria are met: (1) stable or improved eGFR relative to start of treatment (≤ 15% reduction in eGFR) and (2) decrease in UPCR by ≥ 50% relative to start of treatment. Initiation of a complement pathway modulator, initiation/intensification of corticosteroids or immunosuppressants (e.g., MMF) for C3 glomerulopathy, or renal replacement therapy will be determined as failure of the endpoint. |
| Changes in blood urea nitrogen (BUN) | 360 Days | Changes in blood urea nitrogen over the course of treatment |
| Changes in serum albumin | 360 Days | Changes in serum albumin over the course of treatment |
| Changes in serum creatinine | 360 Days | Changes in serum creatinine over the course of treatment |
Countries
Japan
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed